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MEDLINE ECVC8040ARecalls & reported problems

Medline Industries, Inc. · VANTEX 7FR 3L 20CM CVC BUNDLE, CHOICE · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10653160361589), received between Nov 7, 2023 and Sep 28, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Flush” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Difficult to Flush1
  • Material Integrity Problem1

Patient problems

  • Needle Stick/Puncture1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 28, 2026Difficult to Flush

    It was reported that ¿When I initially placed the line the wire went in easily but was bent at an angle when I pulled it out. The line drew normally for the two distal ports but the proximal white port was difficult and I could not pull blood normally, it stopped halfway through and would not draw or flush even when I tried to adjust the line.¿

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50915636 ↗
  • InjuryNov 7, 2023Material Integrity Problem; Material Integrity Problem

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2023 AFTER INSERTING THE NEEDLE HE WAS "UNABLE TO CREATE NEGATIVE PRESSURE WHILE ATTEMPTING TO ASPIRATE BLOOD".

    Patient problems: Needle Stick/Puncture

    MAUDE report 18088755 ↗

Other Cardiac catheterization kit devices

All Cardiac catheterization kit devices →

Sources and updates

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